BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DENTKIST, INC.

    Reg #: 3013012934 · FEI: 3013012934 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    DENTKIST, INC.
    Registration Number
    3013012934
    FEI Number
    3013012934
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    (Dangjeong-dong) 3, Nongshim-ro
    City
    Gunpo-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K152766

    Owner / Operator

    Firm Name
    Dentkist, Inc.
    Operator Number
    10052020
    Address
    (Dangjeong-dong) 3, Nongshim-ro
    City
    Gunpo-si
    State
    Gyeonggi
    Postal Code
    15842
    Country
    KR
    Correspondent
    Shin Heang Lee

    Products

    Device Name Product Code
    Material, Impression ELW
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    CharmFlex®Putty CharmFlex®Putty Green CharmFlex®Bite Clear CharmFlex®Bite Fast CharmFlex®Denture CharmFlex®Bite CharmFlex®Heavy tube type CharmFlex®Putty Soft CharmFlex®Light LV CharmFlex®Light XLV CharmFlex®Light Premium CharmFlex®Heavy cartridge type CharmFlex®Regular CharmFil Plus CharmFil Plus Caps CharmFil Flow Flow Resin ALOOZ

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)